MAUDE Adverse Event Report: ALLERGAN INAMED LAP BAND; IMPLANT, INTRAGASTRIC

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Cramp(s) (2193); Ulcer (2274); Arthralgia (2355)

Event Date 06/01/2003

Event Type  Injury  

Event Description

Lapband inside me for ten years.Numerous health issues associated with it.Severe gastritis, ulcers, intestine infection, esophagus issues, nausea, elevated white blood cell count, severe abdominal pain and cramping fatigue, bone and joint pain.

• Brand Name: INAMED LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 7112050
• MDR Text Key: 94840699
• Report Number: MW5073927
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 42 YR
• Patient Weight: 79